Water Bolus Volumes During Continuous Exercise in Heat | NCT04613856

Studies
Water Bolus Volumes During Continuous Exercise in Heat

NCT04613856

Sponsor

State University of New York at Buffalo

Status

Completed

Last Update Posted

Nov 3, 2020Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Dehydration (Physiology)
Hyperthermia

Interventions

Hydration protocol - 237 mL water bolus
Hydration protocol - 500 mL water bolus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2019Actual

Primary Completion Date

Mar 12, 2020Actual

Completion Date

Mar 12, 2020Actual

First Submitted Date

Oct 30, 2020

First Submission Date that Met QC Criteria

Nov 2, 2020

First Posted Date

Nov 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2020

Last Update Posted Date

Nov 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Riana Pryor, Principal Investigator, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Current Best Practice - 237 mL water bolus	Active Comparator		Other: Hydration protocol - 237 mL water bolus
New Intervention - 500 mL water bolus	Experimental		Other: Hydration protocol - 500 mL water bolus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydration protocol - 237 mL water bolus	Other	Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.	Current Best Practice - 237 mL water bolus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent body mass loss	Percent body mass loss after water intake	2 hours
Core temperature	Core temperature after water intake	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
18-39 y old
Self-reported to be healthy

Exclusion Criteria:

Female
Not within defined age range
History of any cardiovascular, neurologic, or metabolic disease
Current tobacco use or regular use within the last 2 years.
Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
Inability to follow the rules of the protocols or understand the consent form

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Research and Exercise in Special Environments		Buffalo	New York	14214	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD data can be provided upon written request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration
D000084462	Hyperthermia

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided